Quality Systems Specialist

Basic Purpose and Function:Independently perform quality-related functions within the Quality Department. Maintain and monitor quality systems, including document control, change control, CAPA (Corrective and Preventive Actions), internal audits, and complaint handling.Job Responsibilities:Manages the review cycle of customer complaints and CAPAsLead internal audit programAssist in the development, revision, and control of Standard Operating Procedures (SOPs) and other controlled documents.Identify training needs and conduct Quality Assurance-related training to associates in tandem with the Quality ManagerFacilitate the nonconformance process and ensure timely investigation, root cause analysis, and resolution.Supports the maintenance and upkeep of the Quality Management SystemSupport performance metrics system for continual improvementAssist with inspections, document reviews, and data entry when additional support is required to maintain production or quality timelinesOther Responsibilities:Responsible for adhering to the quality system and good manufacturing proceduresMust be able to communicate effectively with the supervisor and co-workers to provide and receive directionsDemonstrate good time management skills independent of supervisionMaintain timely and regular attendance per company policyPerforms other duties as assignedQualifications:Associates degree or equivalent; or 3-5 years related experience and or training; or equivalent combination of education and experience in medical device manufacturingProficient in applicable regulations/standards (ISO 13485, FDA, etc.)Ability to read, analyze, and interpret general business periodicals, professional journals, or governmental regulations.Ability to write reports, business correspondence, and procedure manualsAbility to effectively present information and respond to questions from employees, supervisors, managers, executive staff, customers, and suppliersReaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motionsProficiency in Microsoft Word, Excel, and Outlook or similar e-mail programsResponsible for adhering to the quality system and good manufacturing proceduresMust be able to communicate effectively with the manager and co-workers to provide and receive directionDemonstrate good time management skills independent of supervisionMaintain timely and regular attendance per company policyPhysical Requirements:Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motionsThe associate must occasionally lift and/or move up to 40 poundsSpecific vision abilities required by this job include close vision and the ability to adjust focusPI91f2e3db9d30-26289-40413670